Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device - Safety and Feasibility Study for Treatment of Major Depressive Episode in the Elderly

Depression Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01521052
• Other study ID #: SHA-0001-11
• Status: Not yet recruiting
• Phase: Phase 2
• First received: January 25, 2012
• Last updated: January 27, 2012
• Start date: January 2012

Study information

• Verified date: January 2012
• Source: Shalvata Mental Health Center
• Contact: Dafna Shefet, MD
• Phone: 972-9-7478524
• Email: daphnash[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Purpose: To evaluate the safety and anti-depressive response of the H1 Coil TMS Device in elderly patients suffering from major depressive episode.

Twenty-seven (27) treatment resistance depressed-patients, 68 years of age and above, currently in a depressive episode.All subjects will receive prefrontal deep rTMS of H1 Coil (42 trains of 2 seconds, 10 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold), for 4 weeks, 5 days a week, overall 20 sessions.Safety and efficacy tests will be conducted before starting the trial (screening), once a week for the trial duration and one month following end of treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 27
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 68 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed by a senior psychiatrist as suffering from major depression episode according to DSM-IV (either as a part of a unipolar or a bipolar disorder).

• Rating on HDRS = 20.

• Age: 68 years and above

• Treated for the current depressive episode, at least 6 weeks per antidepressant with one antidepressant in accepted dose, without improvement, and/or intolerance to 2 antidepressants, according to medical chart and ATHF (antidepressant treatment history form) instruction guidelines.

• Gave informed consent for participation in the study.

• Negative answers on safety screening questionnaire for TMS.

• If referred by a treating psychiatrist, he or she approves of the subject's participation in the study.

Exclusion Criteria:

• Axis 2 diagnosis, which is considered prominent to the current depressive episode.

• Substantial suicidal risk as judged by the treating psychiatrist or by an independent psychiatrist.

• Attempted suicide in the past year.

• Cognitive impermanent - if MMSE < 24, patient will be further assessed , and may be excluded according to the primary investigator's discretion

• History of seizure.

• History of epilepsy or seizure in first degree relatives.

• Any CNS disorder that may increase risk of seizure significantly

• History of a significant head injury.

• History of any metal in the head (outside the mouth).

• Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.

• History of frequent or severe headaches.

• Use of hearing aids for hearing loss.

• Known history of cochlear implants.

• History of drug abuse or alcoholism.

• Serious and unstable medical condition, which is likely to exacerbate or endanger the patient during the treatment period.

• Inadequate communication with the patient.

• Under custodial care.

• Participation in current clinical study or clinical study within 30 days prior to this study.

• Patients suffering from bipolar disorder, not currently treated by mood stabilizers

• Patients declared as legally incompetent, with an appointed physical guardian and/or cannot sign informed consent due to cognitive incompetence.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression

Intervention

Device:
• dTMS treatment (H1 Coil)
All subjects will receive prefrontal deep rTMS of H1 Coil (42 trains of 2 seconds, 10 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold), for 4 weeks, 5 days a week, overall 20 sessions.

Locations

Country	Name	City	State
Israel	Shalvata Mental Health Center	Hod Hasharon

Sponsors (1)

Lead Sponsor	Collaborator
Shalvata Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the H1-Coil	maintaining subject's pre treatment, physical and neurological status.	One Month	Yes
Primary	Clinical antidepressant response	a decline in Hamilton depression rating scale (HDRS) from the baseline rating by 50%.	One Month	No
Secondary	Clinical antidepressant remission	exit Hamilton Depression Rating Scale <9.	One Month	No
Secondary	Symptomatic improvement at the end point.	Change in Hamilton Anxiety Rating Scale (HARS), Quick Inventory of Depression Symptomatology - Self Report (QIDS-SR), Clinical Global Impression (CGI).	One Month	No